Tube Crimping Arrangement for Drug Delivery Device

ABSTRACT

A drug delivery system for injecting a medicament is provided. The system includes a container configured to receive a medicament; a drive assembly which, upon actuation, is configured to expel the medicament from the container; a needle for injecting the medicament to a patient; a fluid path assembly comprising a tube in fluid communication with the container and the needle for conducting fluid from the container to the needle; and a tube crimping arrangement configured to engage the tube to block fluid flow through the tube. The drive assembly causes the tube crimping arrangement to engage the tube after a dose of the medicament has been delivered to the patient through the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/160,184 filed Oct. 15, 2018, entitled “Tube Crimping Arrangement forDrug Delivery Device”, which claims priority to U.S. ProvisionalApplication Ser. No. 62/572,692 filed Oct. 16, 2017, entitled “TubeCrimping Arrangement for Drug Delivery Device”, the entire disclosuresof each of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Disclosure

The present disclosure relates generally to a drug delivery or injectordevice and method for delivering a fluid into the body of a patient byinjection and, in particular, to a drug delivery device configured toautomatically provide a fluid lock to prevent fluid from leaking fromthe device after fluid delivery is completed.

Description of the Related Art

Various types of automatic injection devices have been developed toallow drug solutions and other liquid therapeutic preparations to beadministered by untrained personnel or to be self-injected. Generally,these devices include a reservoir that is pre-filled with the liquidtherapeutic preparation, and some type of automatic needle-injectionmechanism that can be triggered by the user. When the volume of fluid ordrug to be administered is generally below a certain volume, such as 1mL, an auto-injector is typically used, which typically has an injectiontime of about 10 to 15 seconds. When the volume of fluid or drug to beadministered is above 1 mL, the injection time generally becomes longerresulting in difficulties for the patient to maintain contact betweenthe device and the target area of the patient's skin. Further, as thevolume of drug to be administered becomes larger, increasing the timeperiod for injection becomes desirable. The traditional method for adrug to be injected slowly into a patient is to initiate an IV andinject the drug into the patient's body slowly. Such a procedure istypically performed in a hospital or outpatient setting.

Certain devices allow for self-injection in a home setting and arecapable of gradually injecting a liquid therapeutic preparation into theskin of a patient. In some cases, these devices are small enough (bothin height and in overall size) to allow them to be “worn” by a patientwhile the liquid therapeutic preparation is being infused into thepatient. These devices typically include a pump or other type ofdischarge mechanism to force the liquid therapeutic preparation to flowout of a reservoir and into the injection needle. Such devices alsotypically include a valve or flow control mechanism to cause the liquidtherapeutic preparation to begin to flow at the proper time and atriggering mechanism to initiate the injection.

SUMMARY OF THE INVENTION

According to an aspect of the disclosure, a drug delivery system forinjecting a medicament is provided. The system includes: a containerconfigured to receive a medicament; a drive assembly which, uponactuation, is configured to expel the medicament from the container; aneedle for injecting the medicament to a patient; a fluid path assemblycomprising a tube in fluid communication with the container and theneedle for conducting fluid from the container to the needle; and a tubecrimping arrangement configured to engage the tube to block fluid flowthrough the tube. The drive assembly causes the tube crimpingarrangement to engage the tube after a dose of the medicament has beendelivered to the patient through the needle.

In some examples, upon actuation, the drive assembly automaticallycauses the tube crimping arrangement to engage the tube. Optionally, thesystem further comprises a housing enclosing at least a portion of thecontainer, drive assembly, needle, fluid path assembly, and tubecrimping arrangement. The housing can include a top cover engaged to abottom cover.

In some examples, the system further includes a needle actuator assemblyhaving a movable portion biased by a biasing member and configured tomove the needle between a pre-use position, a use position for deliveryof the medicament to the patient, and a post-use position after deliveryof the medicament is completed. Optionally, the system further includesa housing enclosing at least a portion of the container, drive assembly,needle, fluid path assembly, and tube crimping arrangement. The needlecan be retracted into the housing in the pre-use and post use positions.At least a portion of the needle can be extended from the housing in theuse position.

In some examples, transition of the needle actuator assembly between theuse position and the post-use position causes the tube crimpingarrangement to engage the tube. For example, upon actuation, the driveassembly can automatically cause the needle actuator assembly totransition the needle between the use position and the post-useposition.

In some examples, the tube crimping arrangement includes at least onetube crimping member configured to be driven toward the tube by contactwith the movable portion of the needle actuation assembly. Optionally,the system further includes a housing enclosing at least a portion ofthe container, drive assembly, needle, and fluid path assembly. The atleast one crimping member can include one or more flexible bladespivotally mounted to a portion of the housing. The movable portion ofthe needle actuator assembly can include one or more pins extendingtherefrom. The pins can be configured to contact the flexible blades todrive the flexible blades towards the tube.

In some examples, the system further includes a housing enclosing atleast a portion of the container, drive assembly, needle, and fluid pathassembly. The at least one crimping member can include two flexibleblades pivotally mounted to a portion of the housing and defining a gaptherebetween. The movable portion of the needle actuator assembly caninclude a first set of pins positioned to deflect the two flexibleblades away from one another to expand the gap and a second set of pinspositioned to drive the two flexible blades towards one another tocontact the tube. Optionally, the movable portion of the needle actuatorassembly includes a ridge configured to press the tube into the gap whenthe gap is expanded by contact between the first set of pins and theflexible blades.

In some examples, the biasing member of the needle actuator assemblyexerts a force of 1N or less on the tube crimping arrangement. In someexamples, the tube is a flexible single walled tube having a diameter of0.7 mm or less.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a drug delivery system according to oneaspect of the present invention.

FIG. 2 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top cover of the housingremoved and the drug delivery system in a pre-use position.

FIG. 3 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a pre-use position.

FIG. 4 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top cover of the housingremoved and the drug delivery system in an initial actuation position.

FIG. 5 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top cover of the housingremoved and the drug delivery system in an in use position.

FIG. 6 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in an in use position.

FIG. 7 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top cover of the housingremoved and the drug delivery system in a post-use position.

FIG. 8 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a post-use position.

FIG. 9A is a cross-sectional view of a drive assembly of the drugdelivery system of FIG. 1 according to one aspect of the presentinvention, showing a pre-use position of the drive assembly.

FIG. 9B is a cross-sectional view of the drive assembly of FIG. 9Aaccording to one aspect of the present invention, showing a use positionof the drive assembly.

FIG. 9C is a cross-sectional view of the drive assembly of FIG. 9Aaccording to one aspect of the present invention, showing a post-useposition of the drive assembly.

FIG. 10 is another top view of the drug delivery system of FIG. 1according to one aspect of the present invention, showing a top cover ofthe housing removed and the drug delivery system in a post-use position.

FIG. 11 is a left side perspective view of a needle shuttle of a needleactuator assembly of the drug delivery system of FIG. 1 according to oneaspect of the present invention.

FIG. 12 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thefluid path assembly and the drug delivery system in a pre-use position

FIG. 13 is a cross-sectional view of a portion of a drug delivery systemincluding a tube crimping arrangement according to an aspect of thepresent invention.

FIG. 14 is a perspective view of a portion of an interior surface of atop cover of the drug delivery system of FIG. 13 according to an aspectof the invention.

FIG. 15 is a perspective view of a portion of the needle actuatorassembly of the drug delivery system of FIG. 13 according to an aspectof the present invention.

FIG. 16 is another cross-sectional view of the drug delivery system ofFIG. 13 according to an aspect of the present invention with the systemin a post-use position.

FIG. 17 is a perspective view of a portion of an interior surface of thetop cover of the drug delivery system of FIG. 13 according to an aspectof the present invention.

FIG. 18 is another perspective view of a portion of an interior surfaceof the top cover of the drug delivery system of FIG. 13 according to anaspect of the present invention.

FIG. 19 is a perspective view of the interior surface of the top coverof the drug delivery system of FIG. 13 according to an aspect of thepresent invention.

FIG. 20 is a cross-sectional view of a portion of another exemplary drugdelivery system including a tube crimping arrangement according to anaspect of the present invention.

FIG. 21 is another cross-sectional view of a portion of the drugdelivery system of FIG. 20 including a tube crimping arrangementaccording to an aspect of the present invention.

FIG. 22 is a schematic drawing of another exemplary drug delivery systemincluding a tube crimping arrangement according to an aspect of thepresent invention.

FIG. 23 is a cross-sectional view of a portion of a drug delivery systemincluding another exemplary tube crimping arrangement according to anaspect of the present invention.

FIGS. 24A and 24B are schematic drawings of a similar tube crimpingarrangement as shown in FIG. 23 according to aspects of the presentinvention.

FIG. 25 is a cross-sectional view of a portion of a drug delivery systemincluding another exemplary tube crimping arrangement according to anaspect of the invention.

FIG. 26 is another cross-sectional view of a portion of the drugdelivery system of FIG. 25 taken at line 26 according to an aspect ofthe present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary aspects of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

A drug delivery system including an injector device for injecting afluid medicament to a patient is provided. The injector device can beconfigured to provide injection of a fluid substance over apredetermined time period. The injector device can be wearable andconfigured to be affixed to a patient. In some examples, the injectioncan occur automatically meaning that, once the user actuates the systemor device, the injection occurs without further action by the patient.In some instances, the injector device includes a drive mechanism thattransitions the device between a pre-use position, a use-position, and apost-use position. For example, transitioning the injector devicethrough the various positions can include causing a needle to extendfrom the device and to be inserted into the patient, expelling fluidmedicament from a container or reservoir of the injector device to thepatient through the needle, and retracting the needle back into thedevice for safe disposal. The injector device can include a cover or padfor covering the tip of the needle after the injection is completed toprevent fluid leaks.

In some examples, the injector device includes a fluid path assembly fortransporting fluid through the injector device. The fluid path assemblycan include a flexible tube or conduit for transporting fluid from thecontainer or reservoir to the needle. In some examples, the injectordevice includes a tube crimping arrangement that is configured toachieve fluid lock of the tube or conduit after the injection iscompleted (e.g., end-of-dose). The fluid lock can supplement protectionprovided by the needle pad or cover and, in particular, can preventfluid from leaking or flowing from the injector device once an injectionis completed. The tube crimping arrangement can be integrated with otherbiasing or movement mechanisms of the injector device, such that thetube is automatically crimped to prevent fluid leak at the end-of-dose.For example, movement of the drive mechanism to transition the devicebetween the use and post-use positions can actuate the tube crimpingmechanism, as discussed herein, by driving crimping or clampingstructures against the tube or conduit to compress the tube or conduitand to prevent fluid flow therethrough.

Exemplary Fluid Delivery System

As shown in FIGS. 1-12, a drug delivery system 10 according to oneaspect of the present invention includes an injector device 2 having adrive assembly 12 (shown in FIGS. 2-8), a container 14, a valve assembly16 (shown in FIGS. 2, 4, 5, 7, and 10), a needle actuator assembly 18(shown in FIGS. 2-8, and a fluid path assembly 200 (shown, example, inFIG. 12) for conducting fluid from the valve assembly 16 to a needle 28(shown in FIGS. 3, 6, and 8) of the needle actuator assembly 18. Thedrive assembly 12, the container 14, the valve assembly 16, the needleactuator assembly 18, and the fluid path assembly 200 are at leastpartially positioned within a housing 20.

As shown in FIG. 1, the housing 20 is formed from a top cover 22 and abottom cover 24, although other suitable arrangements for the housing 20may be utilized. In one aspect, the injector device 2 is configured tobe worn or secured to a user and to deliver a predetermined dose of amedicament provided within the container 14 via injection to thepatient. The drug delivery system 10 and injector device 2 may beutilized to deliver a “bolus injection” where a medicament is deliveredwithin a set time period. The medicament may be delivered over a timeperiod of up to 45 minutes, although other suitable injection amountsand durations may be utilized. A bolus administration or delivery can becarried out with rate controlling or have no specific rate controlling.The system 10 and injector device 2 may deliver the medicament at afixed pressure to the user with the rate being variable.

The injector device 2 is configured to operate by engagement (e.g.,depressing and/or sliding) of an actuation button 26 by a patient.Engagement of the button 26 causes the needle 28 (shown in FIGS. 3, 6,and 8) of the needle assembly 18 to extend from the housing 20 and topierce the skin of the patient. Engagement of the button 26 alsoactuates the drive assembly 12 via the needle actuator (shown in FIGS.2-12), which places the needle 28 in fluid communication with thecontainer 14 through a flexible tube 210 of the fluid path assembly 200(shown, for example, in FIG. 12). Once the container 14 is in fluidcommunication with the needle 28, the drive assembly 12 expels fluid ormedicament from the container 14 and to the patient through the needle28. Once a total desired dose is delivered to the patient, the driveassembly 12 in conjunction with the needle actuator, needle actuatorspring, and release flipper causes the needle 28 to withdraw from theuser and to recede into the housing 20. General operation of anexemplary drug delivery system is shown and described in InternationalPublication Nos. WO 2013/155153 and WO 2014/179774, which are herebyincorporated by reference in their entirety. Additionally, in someconfigurations, the container 14 and valve assembly 16 may be thecontainer and valve assembly shown and described in InternationalPublication No. WO 2015/081337, which is also hereby incorporated byreference in its entirety.

With continued reference to FIG. 1, in some examples, the housing 20 ofthe system 10 includes an indicator window 30 for viewing an indicatorarrangement 32 configured to provide an indication to a user on thestatus of the system 10 and a container window 31 for viewing thecontainer 14. The indicator window 30 may be a magnifying lens forproviding a clear view of the indicator arrangement 32. In someexamples, the indicator arrangement 32 moves along with the needleactuator assembly 18 during use of the system 10 to indicate a pre-useposition, use position, and post-use position of the system 10 anddevice 2. The indicator arrangement 32 provides a visual indicationregarding the device status. As will be appreciated by those of ordinaryskill in the art, other suitable indicators, such an auditory or tactileindicators, may be provided as an alternative or in addition to thevisual indication provided by the indicator arrangement 32.

As shown in FIGS. 2 and 3, during a pre-use position of the injectordevice 2, the container 14 is spaced from the drive assembly 12 and thevalve assembly 16 and the needle 28 is in a retracted position. Thedrive assembly 12 is configured to engage a stopper 34 of the container14 via a spacer component, which will initially move the entirecontainer 14 into engagement with the valve assembly 16, in thedirection of arrow A1 (shown in FIG. 2) due to the incompressibility ofthe fluid or medicament within the container 14.

More specifically, during the initial actuation of the injector device2, as shown in FIG. 4, the drive assembly 12 engages the container 14 tomove the container 14 toward the valve assembly 16, which is configuredto pierce a closure 36 of the container 14 and place the medicamentwithin the container 14 in fluid communication with the needle 28 viathe fluid path assembly 200 (shown in FIG. 12). The initial actuation ofthe system 10 is caused by engagement of the actuation button 26 by auser (e.g., the patient or a caregiver), which releases the needleactuator assembly 18 and the drive assembly 12 as discussed below inmore detail. During the initial actuation, the needle 28 is still in theretracted position and about to move to the extended position to injectthe user of the system 10.

When the device 2 transitions to the use position, as shown in FIGS. 5and 6, the needle 28 is in the extended position, at least partiallyoutside of the housing 20, with the drive assembly 12 moving the stopper34 within the container 14 to deliver the medicament from the container14, through the needle 28, and to the patient. In the use position, thevalve assembly 16 has already pierced the closure 36 of the container 14to place the container 14 in fluid communication with the needle 28,which also allows the drive assembly 12 to move the stopper 34 relativeto the container 14, as shown by arrow A2 (in FIGS. 4 and 5) since fluidis able to be dispensed from the container 14.

At the post-use position of the injector device 2, shown in FIGS. 7 and8, the needle 28 (shown in FIG. 8) is in the retracted position andengaged with a pad 38 to seal the needle 28 and prevent any residualflow of fluid or medicament from the container 14. In addition, asdiscussed hereinafter, a tube crimping mechanism 202 (shown in FIGS.13-18) of the fluid path assembly 200 (shown, for example, in FIG. 12)crimps or clamps against the tube 210 to provide a fluid lock, whichblocks fluid from passing through the tube 210 and to the needle 28. Insome examples, the tube crimping arrangement 202 is driven by the drivemechanism 12 and/or by movement of other portions of the device whichtranslate through the housing 20 as the device 2 transitions from theuse-position to the pose-use position.

Drive Assembly

Referring to FIGS. 2-8, the drive assembly 12 according to one aspect ofthe present invention is shown. As discussed above, the drive assembly12 is configured to move the container 14 in the direction of arrow A1(shown in FIG. 2), to pierce the closure 36 of the container 14 and alsoto move the stopper 34 within the container 14 in the direction of arrowA2 (shown in FIGS. 4 and 5) to dispense fluid or medicament from thecontainer 14. In some examples, the drive assembly 12 can be configuredto dispense a plurality of discrete fill volume ranges. For example, thedrive assembly 12 can include a number of stops or spacers forrestricting or limiting translation of the drive assembly 12 through thehousing 20, thereby limiting the amount of fluid expelled from thecontainer 14. In one example, the injector device 2 can be capable ofdelivering thirteen discrete fluid volumes or doses to the patient. Adesired injection volume can be selected prior to device assembly andthe drive assembly assembled in this configuration.

With reference to FIGS. 9A-9C, elements of the drive assembly 12 whichadvance a plunger member 52 through the container 14 are shown indetail. In some examples, the drive assembly 12 includes the firstplunger member 52, a second plunger member 54 received by the firstplunger member 52, a first biasing member 56, a second biasing member58, a plunger actuation member 60, and an index member 70. The firstplunger member 52 is moveable from the pre-use position (shown in FIG.9A), to the use position (shown in FIG. 9B), to the post-use position(shown in FIG. 9C) with the first plunger member 52 configured to movethe stopper 34 (shown in FIGS. 2-8) within the container 14 to dispensemedicament from the container 14. The first plunger member 52 isconfigured to move axially. The second plunger member 54 and the firstplunger member 52 form a telescoping arrangement with the second plunger54 configured to move axially after the first plunger member 52 moves apredetermined axial distance. The movement of the first and secondplunger members 52, 54 is provided by the first and second biasingmembers 56, 58, which are compression springs, although other suitablearrangements for the biasing members 56, 58 may be utilized.

A drive surface 40 of the plunger actuation member 60 is configured tobe engaged by a portion of the needle actuator assembly 18 (shown inFIGS. 2-8) to effect movement of the needle actuator assembly 18 throughthe housing 20 (shown in FIGS. 2-9) as the injector device 2 transitionsfrom the pre-use position, to the use position, to the post useposition. For example, after engagement of the actuator button 26 andrelease of the needle actuator assembly 18, the needle actuator assembly18 moves within the housing 20 in the direction of arrow A3 (in FIGS.9A-9C). During the initial movement of the needle actuator assembly 18,a portion of the needle actuator assembly 18 engages the drive surface40 of the plunger actuation member 60 to move the plunger actuationmember 60 from the first rotational position to the second rotationalposition.

With reference again to FIG. 7, the second plunger member 54 isconfigured to engage a restriction member 86 of the system 10. Therestriction member 86 cooperates with the needle actuation assembly 18and restricts movement of the needle actuator assembly 18 from the useposition to the post-use position until a predetermined end-of-doseposition of the stopper 34 is reached. Such engagement between therestriction member 86 and the needle actuation assembly 18 is releasedby rotation of the restriction member 86 when the stopper 34 reaches itsend-of-dose position. During the use position of the needle actuatorassembly 18, the restriction member 86 is biased in a rotationaldirection with the rotation of the restriction member 86 being preventedthrough engagement with the second plunger member 54.

With reference to FIG. 10, in some examples, the restriction member inconjunction with the needle actuator is also configured to adjust theposition of the indicator arrangement 32 to identify for the user orpatient the status of the injection (e.g., pre-use, injection occurring,post-use or end-of-dose). Movement of the indicator arrangement 32 canbe viewed through the window 30. More specifically, as shown in FIG. 10,the indicator arrangement 32 engages a portion of the restriction member86 and moves along with the restriction member 86 to reach the firststate and then the indicator arrangement engages a portion of the needleactuator and moves along with the needle actuator to reach the finalstate of the system. Movement of the restriction member 86 can, forexample, rotate the indicator arrangement 32 to provide an indication tothe user regarding the state of the system 10.

Needle Actuator Assembly

Referring to FIGS. 2-10, the needle actuator assembly 18 according toone aspect of the present invention is shown. The needle actuatorassembly 18 includes a needle actuator body 62 having guide surfaces 64,a needle shuttle 102 having cam surfaces 104 (shown in FIG. 11), and theneedle 28 received by the needle shuttle 102 and configured to be influid communication with the container 14 through the fluid pathassembly 200 (shown in FIG. 12). The needle actuator body 62 isgenerally rectangular with the guide surfaces 64 protruding radiallyinward. The needle shuttle 102 is received within the needle actuatorbody 62. The needle actuator body 62 is moveable within the housing 20,as the system transitions from the pre-use position (shown in FIGS. 2and 3), an initial actuation position (FIG. 4), a use position (FIGS. 5and 6), and a post-use position (FIGS. 7 and 8). The needle actuatorbody 62 is biased from the pre-use position to the post-use position viaa biasing member, such as an extension spring 106, although othersuitable biasing arrangements may be utilized. The needle actuator body62 is released and free to move from the pre-use position to the useposition upon engagement of the actuator button 26 and engagement withthe drive mechanism 12 and restriction member 86 as discussed herein.

The needle shuttle 102 is moveable along a vertical axis between aretracted position where the needle 28 is positioned within the housing20 and an extended position where at least a portion of the needle 28extends out of the housing 20. The needle shuttle 102 is configured tomove between the retracted position and the extended position throughengagement between the guide surfaces 64 of the needle actuator 62 andthe cam surfaces 104 (shown in FIG. 11) of the needle shuttle 102. Asshown, for example, in FIG. 11, the cam surface(s) 104 is provided byfirst and second cam members 108, 110, with the first cam member 108spaced from the second cam member 110. The housing 20 includes a guidepost having recess configured to receive a T-shaped projection 114 onthe needle shuttle 102, although other shapes and configurations may beutilized for the guide post and T-shaped projection 114. The needleshuttle 102 moves along the guide post between the retracted andextended positions. The guide post 112 is linear and extends aboutperpendicular from the housing, although other suitable arrangements maybe utilized. The guide surfaces 64 of the needle actuator body 62 may benon-linear and may each include a first side and a second sidepositioned opposite from the first side.

The guide surfaces 64 of the needle actuator body 62 cooperate with thecam members 108, 110 of the needle shuttle 102 to move the needleshuttle 102 vertically between the retracted and extended positions asthe needle actuator body 62 moves axially from the pre-use position tothe post-use position. The needle shuttle 102 also includes a shuttlebiasing member 120 configured to engage the housing 20 or the actuatorbutton 26. In particular, the shuttle biasing member 120 engages thehousing 20 or actuator button 26 and provides a biasing force when theneedle actuator body 62 is transitioning from the use position to thepost-use position.

As shown in FIGS. 7 and 8, when the needle actuator body 62 is fullytransitioned to the post-use position, the cam members 108, 110 (shownin FIG. 11) of the needle shuttle 102 are disengaged from the guidesurfaces 64 of the needle actuator body 62 and the shuttle biasingmember 120 biases the needle shuttle 102 downward such that the needle28 engages the pad 38, as discussed above. The needle actuator body 62may interact with the actuator button 26 to prevent the actuator button26 from popping back up until the post-use position is reached.

Fluid Path Assembly

As shown in FIG. 12, the injector device 2 also includes the fluid pathassembly 200. In general, the fluid path assembly 200 includes theelements of the injector device 2 that contact the medicament fluid plusthe tube crimping mechanism 202 (shown in FIGS. 13-19). For example, thefluid path assembly 200 can include portions of the container 14 (shownin FIGS. 1-10), the stopper 34 (shown in FIGS. 2-10), the valve assembly16, and an adapter for connecting the container 14 with the valveassembly 16. The fluid path assembly 200 also includes the connectingtube 210 (shown in FIG. 12), a port or needle hub 212 for connecting thetube 210 to the needle shuttle 102, and the needle 28. The fluid pathassembly 200 can be provided separately from other components of theinjector device 2 and can be inserted into the injector device 2 priorto use. In that case, the fluid path assembly 200 can be provided with adisposable retainer for holding the components of the fluid pathassembly 200 prior to installation in the bottom cover 24 of the housing20.

To install or assemble the fluid path assembly 200 into the housing 20,the installer unwinds the flexible tube 210 from the disposableretainer. The installer then connect the needle hub or port 212 to anend of the tube 210 and connects the other end of the tube 210 to thecontainer 14 and/or valve assembly 16. The installer then secures theneedle hub or port 212 at the end of an arm portion of the needleshuttle 102 and inserts the container 14 and valve assembly 16 into therespective portions of the bottom cover 24 of the housing 20. Theinstaller then positions or secures portions of the tube 210 against atop surface 214 of the needle actuator body 62, as shown in FIG. 12. Itis noted that the valve module is not physically linked to the primarycontainer, as the fluid path of the valve module is a sub-assembly andis assembled into the bottom case, which can be done independently ofthe assembly of the primary container.

Tube Crimping Arrangement

With reference to FIG. 13, the top case also includes structures forcrimping the tube 210 (shown in FIG. 12) to produce a fluid-block in thetube 210 as the injector device 2 transitions to the post-use or end ofdose position. Collectively, these structures are referred to herein asthe tube crimping arrangement 202. In some examples, as shown in FIGS.13 and 14, the tube crimping arrangement 202 includes one or morecrimping members configured to be driven toward a portion of the tube210 by movement of the needle actuator assembly 18. As discussed herein,the needle actuator assembly 18 is released to travel to the post-usestate by the button and then drive assembly 12 and restriction member(shown in FIGS. 2-8) and translates through the housing 20 to extend andretract the needle 28 (shown in FIGS. 2-8). In some examples, thecrimping members are flexible fins or blades 216 extending from aninterior surface 218 of the top cover 22 of the housing 20. A moldedliving hinge 220 can be disposed along the base of the fins or blade 216to allow the fins or blades 216 to rotate or pivot towards the tube 210.Additional views of the top cover 22 of the housing and blades 216 areshown in FIGS. 17-19. In some examples, flexible blades 216 can beprovided in a side-by-side arrangement to form a swinging gate as shown,for example, in FIGS. 14 and 19. The tube 210 is pushed into the gapbetween the opposing fins or blades 216, such that, when the blades 216are driven together as the device 2 transitions to the post-useposition, the tube 210 is clamped or compressed between the blades 216.The flexible blades 216 can be angled relative to the axis X1 of the topcover 22 of the housing 20, such that the blades 216 both bend and pivottoward the tube 210. For example, the blades 216 can be angled by about10 degrees so that the blades 216 move both axially and radiallyinwardly toward the tube 210.

As shown in FIGS. 13, 15, and 16, the flexible blades 216 can beconfigured to be driven by protrusions, such as pins 222, 224, extendingfrom a top surface 214 of the needle actuator body 62. The pins 222, 224are positioned such that as the needle actuator body 62 translatesthrough the housing 20, the pins 222, 224 contact the flexible blades216, causing the blades 216 to cinch or clamp around the tube 210 toblock fluid flow therethrough.

In some examples, the top surface 214 of the actuator body 62 includestwo pairs of pins (e.g., front pins 222 and rear pins 224) disposed onthe top surface 214 of the needle actuator body 62 and positioned tocontact the blades 216 in a sequential fashion. The top surface 214 ofthe needle actuator body 62 can also include a ridge 226 (shown in FIG.15) extending along the surface between the front pins 222 and the rearpins 224. In some cases, front pins 222 can be disposed on an extensionportion 228 of the top surface 214 so that the spacing between the pins222, 224 is sufficient to crimp the tube 210 in the desired manner. Thefront pins 222 can include angled surfaces 230 positioned to open orsplay apart the blades 216 as shown, for example, in FIG. 16. The angledsurfaces 230 can be angled relative to the longitudinal axis X2 (shownin FIG. 15) of the needle actuator body 62, such that opposing blades216 are pushed apart to increase the gap therebetween.

During actuation of the injector device 2, which is caused by depressingand/or translating the actuation button 26, the needle actuator body 62is directed along the guide surface 64, such that a front portion of theneedle actuator body 62 rocks up at one of its ends in the direction ofarrow B1 in FIG. 16. As a result of the rocking motion, the front pins222 are effectively lifted up to contact the flexible blades 216. Forexample, the angled surface 230 of the pins 22 can contact the blades216 as discussed herein. Contact between the front pins 222 and flexibleblades 216 causes the blades 216 to splay apart to expand the gapbetween the blades 216. As the gap between the blades 216 increases, thetube 210 is pushed up by the ridge 226 on the needle actuator body 62and into the gap. In some examples, the gap can be about 0.5 mm prior toactuation of the injector device 2. The gap can be expanded to about 0.7mm when the blades 216 are splayed apart by the front pins 222.

After the dose of fluid is delivered to the patient in the mannerdescribed hereinabove, the injector device 2 transitions from the useposition to the post-use position. During the transition to the post-useposition, the needle actuator body 62 translates through the housing 20along the guide surface 64 to retract the needle 28. In some examples,the last movement (e.g., the last few millimeters of movement) of theneedle actuator body 62 along the guide surface 64 causes the rear pins224 to deflect the flexible blades 216 forward and radially inwardcausing the blades 216 to pinch or clamp against the flexible tube 210.Desirably, the force required to maintain the pinch or clamp of the tube210, as a result of the pressure applied on the blades 216 from the rearpins 224, is minimized and, preferably is less than or equal to about1N.

Force exerted by the biasing member or extension spring 106 may beminimized in the following manner. Under force of the extension spring106, the blades 216 may be moved a distance of 1 mm to 2 mm to minimizethe gap between the blades 216. In this position, each blade 216 exertsa force of about 0.5 N on the tube needle actuator body 62, meaning thata total force of about 1N is provided by the needle actuator body 62 andthe extension spring 106. Movement of the blades 216 to clamp or cinchthe tube 210 causes the tube 210 to compress, which produces atransverse or side load on the tube 210. The force of the transverse orside load can be about 3N. As the blades rotate and flex inwards topinch the tube the transverse or side loads increase but the axial forcereduces, this reducing force must be provided through the blades 216 bythe needle actuator body 62 and the extension spring 106. This reductionin force applied by the extension spring 106 for cinching or clampingthe tube 210 suggests a toggling action. For example, the tube 210 canbe positioned to permit over-centering or toggle action of the flexibleblades 216 so that the residual force required by the needle actuatorbody 62 and extension spring 106 to maintain the cinch or clamp of thetube 210 is minimal.

It is believed that the 3N transverse or side load is sufficient to sealoff flow of a thin wall tube having a double wall thickness of about 0.7mm. In other examples, a thick walled tube having a double wallthickness of about 1.3 mm may be used. However, when using a thickwalled tube, slightly more force or compression may be required to sealoff the flow through the tube. Care must also be taken to ensure thatthe living hinge 220 of the blades 216 maintains sufficient flexibilityso that the blades 216 contact and cinch the tube 210. Element analysisdemonstrates that maximum shear rate for the injection should be below40,000. In some cases, injections performed using the drug deliverydevice should be performed slightly faster than standard injections toprevent the living hinge 220 on the flexible blades 216 from freezingoff due to shear.

Additional Exemplary Tube Crimping Arrangements

Another example of an injector device 300 with a tube crimpingarrangement 302 for a flexible tube 310 is illustrated in FIGS. 20 and21. As in previously described examples, the device 300 includes ahousing 320 formed from a top cover 322 and bottom cover 324. The tubecrimping arrangement 302 is simplified by replacing the pins andflexible blades of previously described embodiments with a sharp edge316, which extends inwardly from an interior surface 318 of the topcover 322, and wedge 326 of a needle actuator body 362. The wedge 326 ispositioned to drive the tube 310 toward the sharp edge 316 to compressthe tube 310, thereby blocking fluid flow therethrough. As previouslydescribed, at the end-of-dose, the needle actuator body 362 translatesthrough the housing 20 in the direction of arrow Cl. Movement of theneedle actuator body 362 through the housing 320 pushes the tube 310toward the sharp edge 316. A small bore tube only requires about 1 mm ofcompression. As such, the needle actuator body 62 needs to move the tube310 toward the sharp edge 316 by about 0.5 mm to close the gap betweenthe wedge 326 of the needle actuator body 362 and the edge 316 of thetop cover 322.

Another example of an injector device 400 including a tube crimpingarrangement 402 for a flexible tube 410 is illustrated in FIG. 22. Thetube crimping arrangement 402 can be configured to kink the tube 410 toblock fluid flow therethrough. The tube 410 can be placed in a housing420 of the injector device 400 such that a portion 411 of the tube 410is curved about guide structure(s) 416 to impart a bend to the tube 410.For example, the guide structure(s) 416 can be posts or protrusionswhich direct the tube 410 in a curved path. As a needle actuator body462 translates through the housing 420 at end-of-dose, a portion 426 ofthe needle actuator body 462 is pressed against the curved portion 411of the tube 410 to place a kink in the tube 410. Specifically, thecurved portion 411 of the tube 410 is pressed, in the direction of arrowD, against the guide structure 416 to produce the kink.

Another example of an injector device 500 including a tube crimpingarrangement 502 for a flexible tube 510 is illustrated in FIGS. 23-24B.As shown in FIG. 23 and as previously described, the injector device 500includes a housing 520 formed from a top cover 522 and a bottom cover524. The tube crimping arrangement 502 may include a wedge shapedportion 516 extending from an inner surface 518 of the top cover 522 ofthe housing 520. A needle actuator body 562, which translates throughthe housing 520 as the injector device 500 transitions to the post useposition, may include a pinching portion 526 configured to press againstthe tube 510. Specifically, as shown in FIGS. 24A and 24B, as the needleactuator body 562 is driven through the housing 520 in the direction ofarrow E1, the wedge 516 directs the pinching portion 526 of the needleactuator body 562 toward the tube 510, in the direction of arrow E2. Themovement of the needle actuator body 562 compresses the tube 510 againsta portion of the bottom cover 524 of the housing 520. In some examples,the bottom cover 524 can include a protrusion 564 (shown in FIG. 24A) orretention structure for maintaining the position of the tube 510 whenthe pinching portion 526 of the needle actuator body 562 is pressedagainst it. In other examples, the bottom cover 524 can include a curvedsurface 566 (shown in FIG. 24B) or depression for receiving the tube510. Other pinching or camming structures for compressing the tube 510as the needle actuator body 562 translates through the housing 520 mayalso be constructed within the scope of the present disclosure, as willbe apparent to those of ordinary skill in the art.

Another example of an injector device 600 including a tube crimpingarrangement 602 for a flexible tube 610 is shown in FIGS. 25 and 26. Asin previously described examples, the injector device 600 includes ahousing 620 formed from a top cover 622 and a bottom cover 624. A needleactuator body 662 is disposed in the housing 620 and configured totranslate through the housing 620 as the device 600 transitions from itsuse position to a post-use position. The tube crimping arrangement 602includes a clamp 626 extending from the needle actuator body 662. Asshown in FIG. 26, the clamp 626 includes a channel 630 formed fromopposing walls 632. Element 628 is a rigid feature of the needleactuator and the tube 610 is positioned with element 628 during use.When the needle actuator moves to the post-use position, the tube iswedged up into the features on the top of the case thereby pinching thetube and blocking flow. These are two channels to accommodate twodifferent pinches required for different inner tube diameters. The tubemay be assembled in the one relating to its appropriate inner diameterduring assembly.

Elements of one disclosed aspect can be combined with elements of one ormore other disclosed aspects to form different combinations, all ofwhich are considered to be within the scope of the present invention.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. An injector device comprising: a housing; acontainer positioned in the housing configured to contain a fluid; adrive assembly positioned in the housing which, upon actuation, isconfigured to expel the fluid from the container; a needle for injectingthe fluid to a patient; a needle actuator assembly comprising a movableportion biased by the drive assembly to move the needle between apre-use position in which the needle is in the housing, a use positionin which at least a portion of the needle protrudes from the housing fordelivery of the fluid to the patient, and a post-use position afterdelivery of the fluid is completed in which the needle is within thehousing; a fluid path assembly in the housing comprising a tube in fluidcommunication with the container and the needle for conducting fluidfrom the container to the needle; and a tube crimping arrangementconfigured to engage the tube to block fluid flow through the tube,wherein after a dose of the fluid has been delivered to the patientthrough the needle, the drive assembly moves the movable portion of theneedle actuator assembly to contact a portion of the tube, which pressesthe tube against the tube crimping to at least partially restrict fluidflow through the tube.
 2. The injector device of claim 1, wherein thehousing comprises a top cover and a bottom cover, which are mountedtogether to at least partially enclose the container, drive assembly,needle, fluid path assembly, and tube crimping arrangement.
 3. Theinjector device of claim 2, wherein the tube crimping arrangementincludes an edge member extending inwardly from an interior surface ofthe top cover of the housing, said edge member configured to engage thetube to block fluid flow through the tube.
 4. The injector device ofclaim 3, wherein the movable portion of the needle actuator assemblycomprises a wedge member comprising an angled surface that moves theportion of the tube towards the top cover of the housing, therebypressing the tube against the edge member.
 5. The injector device ofclaim 4, wherein the wedge member moves the portion of the tube towardsthe edge member a distance of about 0.5 mm to restrict fluid flowthrough the tube.
 6. The injector device of claim 1, wherein tubecrimping arrangement comprises at least one guide structure having acircular cross section, and wherein a portion of the tube is positionedabout the at least one guide structure.
 7. The injector device of claim6, wherein the movable portion of the needle actuator assembly pressesthe portion of the tube against the at least one guide structure,thereby producing a kink in the tube to restrict fluid flow through thetube.
 8. The injector device of claim 1, wherein the housing comprises atop cover and a bottom cover, which are mounted together to at leastpartially enclose the container, drive assembly, needle, fluid pathassembly, and tube crimping arrangement, and wherein the tube crimpingarrangement comprises a wedge shaped portion extending inwardly from thebottom cover.
 9. The injector device of claim 1, wherein the tubecrimping arrangement comprises a clamp extending from the needleactuator body, said clamp including at least one channel configured forreceiving the tube to restrict fluid flow.
 10. The injector device ofclaim 1, wherein, upon actuation, the drive assembly automaticallycauses the movable portion of the needle actuator assembly to press thetube against the tube crimping arrangement.
 11. The injector device ofclaim 1, wherein, upon actuation, the drive assembly automaticallycauses the needle actuator assembly to transition the needle from thepre-use position to the post-use position.
 12. The injector device ofclaim 1, wherein the drive assembly comprises at least one plungerconfigured to move a stopper within the container to dispense the fluidfrom the container and at least one biasing member configured to movethe at least one plunger through the housing and to move the movableportion of the needle actuator assembly through the housing.
 13. Theinjector device of claim 12, wherein the biasing member comprises acompression spring.
 14. The injector device of claim 12, wherein thebiasing member exerts a force of 1N or less on the at least one plungerand on the movable portion of the needle actuator assembly.
 15. Theinjector device of claim 1, wherein the tube comprises a flexible singlewalled tube having a diameter of 0.7 mm or less.
 16. The injector deviceof claim 1, wherein the fluid contained in the container comprises aliquid drug to be injected to the patient.